Lead Clinical Research Coordinator - Trials & Compliance

Folio Clinical Research; Arlington (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Folio Clinical Research in Arlington, TX, is seeking a Lead Clinical Research Coordinator to manage daily trial activities under the PI. You will ensure regulatory compliance, data integrity, and study milestones while collaborating with investigators, sponsors, and site staff.

The ideal candidate has 5+ years of CRC experience, proficiency with EDC, CTMS, and eTMF systems, and a strong understanding of ICH-GCP.

Qualifications

• 5+ years of Clinical Research Coordinator experience.
• Experience with EDC, CTMS, and eTMF systems.
• Knowledge of ICH-GCP and regulatory requirements.
• Experience ensuring patient safety and data integrity.
• Strong communication with internal and external stakeholders.

Responsibilities

• Ensure regulatory compliance with federal regulations and sponsor requirements.
• Maintain secure storage of study documents and consent forms.
• Support PI to meet IRB approvals and study timelines.
• Coordinate with Sponsors, CROs, and internal teams.
• Participate in SQVs, SIVs, IMVs and other study meetings.
• Identify obstacles and propose solutions to maintain study momentum.
• Manage inventory and equipment for the trial.

Skills

Clinical leadership

Regulatory compliance

Communication

Problem solving

Attention to detail

Multitasking

Self-driven

Education

Bachelor's degree or equivalent

Tools

CTMS

eTMF

EDC

IXRS

RTSM

Job description

Folio Clinical Research in Arlington, TX, is seeking a Lead Clinical Research Coordinator to manage daily trial activities under the PI. You will ensure regulatory compliance, data integrity, and study milestones while collaborating with investigators, sponsors, and site staff.

The ideal candidate has 5+ years of CRC experience, proficiency with EDC, CTMS, and eTMF systems, and a strong understanding of ICH-GCP.